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Company's medical device earns expedited review

December 9, 2009

Indianapolis-based FAST Diagnostics LLC, a developer of medical testing technologies, said Wednesday morning that the U.S. Food and Drug Administration has granted it an expedited review of its promising method to assess kidney function more efficiently.

“It was especially gratifying that the FDA determined we had demonstrated that this is ‘breakthrough technology’ that may provide a clinically meaningful advantage,” company CEO Joe Muldoon said in a prepared statement. “This will help accelerate our pursuit of human trial data, and eventual market launch.”

Initial human trials could begin as early as next year, with commercialization following by 2012. Muldoon has estimated that $11 million to $15 million will need to be raised from investors to complete the tests.

Founded in 2006, the company is turning an Indiana University discovery into a method to measure kidney function faster and more accurately than existing techniques. While FAST represents speed, the name actually stands for functional assessment and surveillance technology.

FDA requirements for medical devices seeking an expedited review require that devices must treat or diagnose a life-threatening disease and address an unmet medical need. The expedited status will allow FAST’s study results to receive priority during the approval process.

FAST's technology measures the body's kidney function, known as glomerular filtration rate, or GFR, by monitoring inert markers that have been injected into a patient's bloodstream. A fiber-optic device inserted into a vein through a catheter tracks the markers, measuring how effectively the body filters waste and giving an accurate filtration rate reading in less than an hour.

Current methods to assess kidney function measure creatinine, a compound in the muscles and blood that is passed in urine. It typically takes 24 hours to collect the sample.

FAST received a $2 million grant last year from the state’s 21st Century Research and Technology Fund. 

 

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